HAND SANITIZER- alcohol gel 
Ripshot Enterprises Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (4% v/v).
  3. Hydrogen peroxide (0.1251% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Polyquaternium-10 (1%v/v) for its anti-static and moisturizing properties

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, Polyquaternium-10

Ripshot Hand Sanitizer Formula

59.1471mL NDC: 78586-435-02 59.1 mL Label

OR

2oz Alternative Label

118.294mL NDC: 78586-435-04

118.2mL Label

OR

4oz Alternate Label

236.588mL NDC: 78586-435-08 236.5mL Label

473.176mL NDC: 78586-435-16

473.1 mL Label]

OR

16oz Alternative Label

946.353mL NDC: 78586-435-32 946.3 m/L Label

OR

1L Alternative Label

3785.41mL NDC: 78586-435-40

128oz Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78586-435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981) 1 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.00049 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 24.8744 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78586-435-0259.1471 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/30/2020
2NDC:78586-435-04118.294 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/30/2020
3NDC:78586-435-08236.588 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/30/2020
4NDC:78586-435-16473.176 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/30/2020
5NDC:78586-435-32946.353 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/30/2020
6NDC:78586-435-403780 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Ripshot Enterprises Corp (241994209)
Registrant - Ripshot Enterprises Corp (241994209)
Establishment
NameAddressID/FEIBusiness Operations
Ripshot Enterprises Corp241994209manufacture(78586-435)

Revised: 8/2020
Document Id: ad29db66-f589-dc4f-e053-2a95a90aae6e
Set id: a8c50f59-d3bc-008d-e053-2a95a90ac217
Version: 3
Effective Time: 20200818
 
Ripshot Enterprises Corp